Medical Readiness: DOD Continues to Face Challenges in Implementing Its
Anthrax Vaccine Immunization Program (Testimony, 04/13/2000,
GAO/T-NSIAD-00-157).

Pursuant to a congressional request, GAO discussed the Department of
Defense's (DOD) anthrax vaccine immunization program, focusing on: (1)
vaccine supply; (2) medical records; and (3) efforts to educate
servicemembers about the program.

GAO noted that: (1) in October 1999, GAO reported on challenges to
implementing DOD's anthrax immunization program; (2) GAO noted that
supply problems caused by the manufacturer's inability to obtain Food
and Drug Administration (FDA) approval to distribute vaccine
manufactured at its renovated facility and problems testing previously
stockpiled vaccine jeopardized DOD's schedule for vaccinating all 2.4
million servicemembers; (3) this fundamental requirement of the
program--maintaining an adequate supply of the vaccine--has not yet been
met; (4) program officials expect the current supply to last until July
2000; (5) although program officials expect FDA to approve the release
of previously stockpiled vaccine before the available supply is
depleted, this expectation may be optimistic given past testing
problems; (6) DOD is vaccinating only personnel who are being deployed
to high-threat areas and has delayed vaccinations of personnel in units
scheduled for early deployment; (7) if the manufacturer does not obtain
FDA approval as expected, DOD may be forced to halt vaccinations, at
least temporarily; (8) moreover, DOD still lacks a contingency plan in
the event supply problems are not resolved in time; (9) GAO reported
that DOD's recording and tracking system of servicemembers who receive
vaccinations is an improvement over the system used during the Gulf War
and in Bosnia but that DOD was not meeting its requirement to record
vaccination data consistently both in paper records and in its central
database; (10) DOD reported that it planned to take further steps to
improve its central database; (11) also, GAO recommended that DOD
collect data on the number of servicemembers refusing the vaccine so
that it can better understand servicemembers' concerns; (12) to date,
the Army has drafted a policy to collect data every 3 months; (13) the
other services are not planning to require periodic reporting but will
provide data on vaccine refusals when requested; (14) the results of
GAO's survey showed that servicemembers wanted more information on
long-term side effects and procedures for reporting possible side
effects from the vaccine; (15) DOD has taken initiatives to carry out a
high-visibility education campaign to inform servicemembers about the
vaccine program; and (16) for example, DOD has implemented a speakers'
bureau, has updated its Internet site, and is sponsoring studies of
health effects related to the vaccine.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-NSIAD-00-157
     TITLE:  Medical Readiness: DOD Continues to Face Challenges in
	     Implementing Its Anthrax Vaccine Immunization Program
      DATE:  04/13/2000
   SUBJECT:  Immunization programs
	     Safety standards
	     Defense procurement
	     Military personnel
	     Product safety
	     Health hazards
	     Medical information systems
	     Biological warfare
	     Medical records
IDENTIFIER:  DOD Anthrax Immunization Program

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Thursday,

April 13, 2000

GAO/T-NSIAD-00-157

Medical Readiness

DOD Continues to Face Challenges in Implementing Its Anthrax Vaccine
Immunization Program

        Statement of Carol R. Schuster, Associate Director

National Security Preparedness Issues

National Security and International Affairs Division

Testimony

Before the Committee on Armed Services, U.S. Senate

United States General Accounting Office

GAO

Mr. Chairman and Members of the Committee:

We are pleased to be here today to discuss our past work on the Department
of Defense's (DOD) anthrax vaccine immunization program. As you know, DOD
regards the biological agent anthrax, an infectious disease that is
99--percent lethal if inhaled by unprotected humans, as the single greatest
biological weapon threat to U.S. military forces. DOD considers vaccination
one of the measures critical to protecting U.S. forces against such weapons.
In December 1997, the Secretary of Defense announced a plan to immun-ize all
active and reserve military personnel with a licensed anthrax vaccine. In
August 1998, DOD began immunizing all 2.4 million U.S. military
personnel-including all active and reserve personnel-against anthrax.

Today we would like to provide a brief update on three key findings of our
October 1999 report. The findings relate to vaccine supply, medical records,
and efforts to educate servicemembers about the program. We have also
reviewed other aspects of the anthrax vaccine immunization program,
including the safety and efficacy of the vaccine and the contracts with the
manufacturer. Our related reports are listed in an attachment to this
statement.

Summary

Second, we reported that DOD's recording and tracking system of
servicemembers who receive vaccinations is an improvement over the system
used during the Gulf War and in Bosnia but that DOD was not meeting its
requirement to record vaccination data consistently both in paper records
and in its central database. DOD reported that it planned to take further
steps to improve its central database. Also, we recommended that DOD collect
data on the number of servicemembers refusing the vaccine so that it can
better understand servicemembers' concerns. To date, the Army has drafted a
policy to collect data every 3 months. The other services are not planning
to require periodic reporting but will provide data on vaccine refusals when
requested.

Finally, we reported on the results of our survey, which showed that
servicemembers wanted more information on long-term side effects and
procedures for reporting possible side effects from the vaccine. DOD has
taken initiatives to carry out a high-visibility education campaign to
inform servicemembers about the vaccine program. For example, it has
implemented a speakers' bureau, has updated its Internet site, and is
sponsoring studies of health effects related to the vaccine.

Supply Problems Jeopardize Vaccination Program

First, the manufacturer, BioPort Corporation, Lansing, Michigan, has yet to
receive FDA approval of its manufacturing processes following a 17-month
shutdown of the facility for renovation. Until BioPort obtains this approval
and additional approvals for the release of each lot, it cannot release lots
produced after the renovation. According to a DOD contractor's assessment of
a November 1999 FDA inspection report, the FDA identified 30 deficiencies,
largely dealing with BioPort not fully complying with FDA Good Manufacturing
Practice regulations. The assessment noted that there may be at least two
significant issues BioPort must address, namely implementing a program to
validate vaccine manufacturing and testing processes and systems to ensure
product quality. DOD has taken several initiatives to support and oversee
BioPort's efforts to obtain FDA approval. According to a contracting
official, DOD intends to order BioPort to stop production of the vaccine and
focus efforts on measures to validate the manufacturing process. DOD also
plans to assist BioPort by funding consultants to help BioPort obtain FDA
approval and to keep the facility operating at a low level. DOD officials
estimate BioPort will not obtain FDA approval of its manufacturing processes
until late 2000. BioPort's inability to obtain FDA approval of its anthrax
production processes has led to serious cash flow problems. Further delays
will only exacerbate these problems.

Second, unless the currently available 273,000 doses are augmented with
additional approved vaccine from the stockpile, the program will be without
vaccine from July through late 2000 (or whenever BioPort obtains FDA
approval) if it continues administering vaccinations at its current rate.
When the manufacturer suspended production in January 1998 to undertake
renovations, it still had 40 lots of anthrax vaccine stockpiled at its
plant. Of these, 31 had passed all the tests and had received FDA approval
for release. To ensure that no changes had taken place in the approved
vaccine since FDA granted approval, DOD decided to subject the 31 approved
lots to a series of supplemental tests for purity, potency, sterility, and
safety. Since supplemental testing began in January 1998, 11 of the 31 lots
have been made available for use; but 20 lots are still unavailable due to
test failures or problems with the tests themselves. For example, some
vaccine lots did not contain sufficient levels of a required preservative
(test failure), while testing of other lots may have been invalidated
because underweight guinea pigs were used as test subjects (test problems).
For the remaining nine lots produced just before the renovation shutdown,
BioPort needed only to obtain the normal FDA approval for release. As of
April 10, 2000, five of these nine lots had been approved for release. In
sum, only 16 of the 40 vaccine lots in the stockpile have been released, and
according to program officials, almost all have already been used by the
program.

Program officials plan to conduct tests on and obtain FDA approval for
release of a limited number of stockpiled lots, thus augmenting the
currently available doses before they are depleted. They estimate that this
will provide sufficient vaccine to continue the program until FDA grants
permission to release lots produced after BioPort's renovation, possibly by
late 2000. Our analysis shows that DOD's time frames for testing and gaining
FDA approval of these stockpiled lots may be optimistic. For example, it
assumes that FDA will expedite approval of a revised testing protocol and
final test results and that BioPort will not encounter testing problems as
it has in the past.

Because of the limited vaccine supply, DOD is vaccinating only personnel who
have deployed to high-threat areas and has delayed vaccinations of personnel
in units scheduled for early deployment. The original date to begin
vaccinating this latter population was January 2000. In response to our
recommendation, DOD drafted a contingency plan to ensure the continued,
measured implementation of the program, but the Office of the Secretary of
Defense has not yet approved this plan.

Recording and Tracking of Vaccinations Have Improved, but Further
Improvements Are Possible

These problems were caused in part by delays in updating data on information
in the central database. For example, delays in updating data on
individuals' duty stations impeded DOD's ability to use its central database
to manage vaccination schedules and assess unit readiness. Commanders need
updated duty station information to ensure that their personnel receive
vaccinations on time and are ready for deployment. An accurate centralized
database is also important for tracking which vaccine lots are administered,
should health concerns about a specific lot emerge. In its response to our
report, DOD said it would take aggressive steps to ensure the timely and
accurate updating of personnel data in the database.

In addition, at the time of our review, DOD had not collected data on
personnel who refused vaccination or left the service to avoid vaccination.
DOD thus did not have an important tool to gauge the extent of resistance to
the program and target training resources to give servicemembers needed and
wanted information. In its response to our report, DOD said that it was
reviewing a draft policy memorandum on reporting servicemembers' refusals to
be vaccinated. In April 2000, a program official told us that this policy
will apply only to the Army and will require major commands to provide
quarterly reports on soldiers who refuse the vaccine. The other services are
not planning to require periodic reporting but will provide data on vaccine
refusals when requested. According to the program official, a servicemember
is considered to have refused the vaccine only after he or she initially
declines the vaccine, receives education and counseling (either verbally or
in writing), and then disobeys a direct order to take the vaccine.

DOD Has an Extensive Education Campaign and Has Begun to Monitor Its
Effectiveness

At the time of our survey, DOD had not monitored the effectiveness of its
educational campaign. But after our survey, DOD initiated several steps to
improve its educational campaign. It established a communications division
to focus on servicemembers' information needs. The division updated the
program's Internet site and set up a toll-free information line and a
traveling speakers' bureau of experts on anthrax and the vaccine. DOD has
also begun monitoring its educational efforts. Specifically, the program now
surveys servicemembers who have begun or are scheduled to begin the series
of anthrax vaccinations. The survey collects information on the
availability, timeliness, and effectiveness of the program's educational
materials.

In its comments to our October report, DOD stated that it had taken several
actions to improve guidance and training on reporting adverse events
associated with the vaccine. These actions included updating or developing
briefings and fact sheets required to be given to servicemembers and
clinicians and providing links to adverse event reporting forms through
DOD's anthrax vaccine Internet site. We have not assessed these actions or
evaluated their impact on the reporting of adverse health events.

To address questions regarding the safety of the anthrax vaccine, DOD
established a Longitudinal Studies Concept Committee to define research
needs and identify subsequent research designs. The Committee, which
includes members from DOD, FDA, the Centers for Disease Control and
Prevention, and the Armed Forces Epidemiological Board, met in August and
September 1999 and recommended some research designs. One of the studies
being planned is a prospective study of servicemembers that will follow the
health effects over multiple years of vaccine and non-vaccine recipients.
This study is scheduled to begin in 2001.

Mr. Chairman and Members of the Committee, this concludes our formal
statement. We would be happy to answer any questions you may have.

Contact and Acknowledgments

Attachment

Related GAO Products

Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine
Immunization Program (GAO/NSIAD-00-36, Oct. 22, 1999).

Anthrax Vaccine: Safety and Efficacy Issues (GAO/T-NSIAD-00-48, Oct. 12,
1999).

Medical Readiness: Issues Concerning the Anthrax Vaccine
(GAO/T-NSIAD-99-226, July 21, 1999).

Contract Management: Observations on DOD's Financial Relationship With the
Anthrax Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

Medical Readiness: Safety and Efficacy of the Anthrax Vaccine
(GAO/T-NSIAD-99-148, Apr. 29, 1999).

Chemical and Biological Defense: Observations on DOD's Plans To Protect U.S.
Forces (GAO/T-NSIAD-98-83, Mar. 17, 1998).

Defense Health Care: Medical Surveillance Improved Since Gulf War, But Mixed
Results in Bosnia (GAO/NSIAD-97-136, May 13, 1997).

Chemical and Biological Defense: Emphasis Remains Insufficient to Resolve
Continuing Problems (GAO/NSIAD-96-103, Mar. 29, 1996).

Chemical and Biological Defense: Emphasis Remains Insufficient to Resolve
Continuing Problems (GAO/T-NSIAD-96-123, Mar. 12, 1996).

(702065)

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